Myomo (0M61) Risk Analysis
Risk Overview Q1, 2026
Source: the company's latest filing for the period ended Mar 31, 2026, filed May 07, 2026
Risk Change Over Time
Risk Highlights Q1, 2026
Risk Word Cloud
Risk Factors Full Breakdown - Total Risks 16
- Accounting & Financial Operations - Risk 1Risks Related to Internal Controls
We are a "smaller reporting company” under the reporting rules set forth under the Exchange Act. For so long as we remain a “smaller reporting company,” we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not “smaller reporting companies.” We are a “smaller reporting company,” for as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not “smaller reporting companies,” including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (so long as we remain a non-accelerated filer) and reduced disclosure obligations regarding executive compensation in the Annual Report on Form 10-K and our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. We are obligated to develop and maintain a system of effective internal control over financial reporting. We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may harm investor confidence in our company and, as a result, the value of our common stock. We are required, pursuant to Section 404 of the Sarbanes-Oxley Act (“Section 404”) to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting in the annual and quarterly reports we file with the SEC. This assessment will need to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. However, our auditors are not required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer a “smaller reporting company” as set forth under the Exchange Act. During 2025, we undertook efforts to remediate a material weakness in information technology general controls. As of December 31, 2025, we assessed that the material weakness was remediated and that our disclosure controls and procedures were effective. We will need to continue to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. As we continue to grow, we may need to add additional finance staff. Despite our efforts, from time to time we may not be able to conclude that our internal control over financial reporting is effective as required by Section 404. If we are unable to assert that our internal control over financial reporting is effective, or if our auditors are unable to express an opinion on the effectiveness of our internal controls when they are required to issue such opinion, investors could lose confidence in the accuracy and completeness of our financial reports, which could harm our stock price. The preparation of our financial statements involves the use of estimates, judgments and assumptions, and our financial statements may be materially affected if such estimates, judgments or assumptions prove to be inaccurate. Financial statements prepared in accordance with accounting principles generally accepted in the United States typically require the use of estimates, judgments and assumptions that affect the reported amounts. Often, different estimates, judgments and assumptions could reasonably be used that would have a material effect on such financial statements, and changes in these estimates, judgments and assumptions may occur from period to period over time. Significant areas of accounting requiring the application of management’s judgment include, but are not limited to, determining the fair value of assets and the timing and amount of cash flows from assets. These estimates, judgments and assumptions are inherently uncertain and, if our estimates were to prove to be wrong, we would face the risk that charges to income or other financial statement changes or adjustments would be required. Any such charges or changes could harm our business, including our financial condition and results of operations and the price of our securities. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of the accounting estimates, judgments and assumptions that we believe are the most critical to an understanding of our financial statements and our business. We are incurring increased costs as a public company and our management team is required to devote substantial time to new compliance initiatives and corporate governance practices. As a public company, and particularly after we are no longer a “small reporting company,” we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the NYSE American and other applicable securities rules and regulations impose various requirements on public companies. Our management and other personnel will need to devote a substantial amount of time to compliance with these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.
- Accounting & Financial Operations - Risk 2Cautionary statement regarding forward-looking statements
Some of the statements under “Business,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this Annual Report on Form 10-K constitute forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms or other comparable terminology.You should not place undue reliance on forward looking statements. The cautionary statements set forth in this Annual Report on Form 10-K, including in “Risk Factors” and elsewhere, identify important factors which you should consider in evaluating our forward-looking statements. These factors include, among other things: •our ability to achieve or obtain sufficient reimbursement from third-party payers for our products;•our dependence on external sources for the financing of our operations;•our ability to scale the business to return to positive cash flow from operations;•our revenue concentration with Medicare Part B insurance coverage;•our ability to continue normal operations and patient interactions without supply chain disruption in order to deliver and fit our custom-fabricated devices;•our marketing and commercialization efforts;•our ability to obtain and maintain our strategic collaborations and to realize the intended results of such collaborations;•our ability to effectively execute our business plan and scale up our operations;•our expectations as to our product development programs, including improving our existing products and developing new products;•our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products;•our expectations as to our clinical research program and clinical results;•our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;•our ability to gain and maintain regulatory approvals;•our ability to compete and succeed in a highly competitive and evolving industry; and•general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients; and•other risks and uncertainties, including those listed under the captain “Risk Factors” in this Annual Report on Form 10-K. Although the forward-looking statements in this Annual Report on Form 10-K are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as maybe be required by law, to re-issue this Annual Report on Form 10-K or otherwise make public statements updating our forward-looking statements.44
- Accounting & Financial Operations - Risk 3Risks Related to Our Operating and Financial Results
We have a history of operating losses. Investments in advertising, R&D and clinical, reimbursement and manufacturing capacity could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis. We have a history of losses since inception. For the years ended December 31, 2025 and 2024 we incurred net losses of $15.6 million and $6.2 million, respectively. At December 31, 2025, we had an accumulated deficit of approximately $118.1 million. The extent and duration of future operating and net losses will depend on our ability to increase revenues, increase the number of patients entering our pipeline at a lower advertising cost per addition to our patient pipeline, or Cost Per Pipeline Add, our ability to manage fixed costs associated with clinical, reimbursement and manufacturing capacity and our ability to compensate for an elevated level of research and development ("R&D") spending. However, there can be no assurance that we can cost effectively grow our revenues without requiring additional capital. Our cash, cash equivalents and short-term investments at December 31, 2025 were approximately $18.4 million. On November 4, 2025, we entered into a Loan and Security Agreement (the "Loan and Security Agreement") with Avenue, which provided us with $17.5 million in committed funding under two tranches. The first tranche of $12.5 million was funded at closing on November 4, 2025. A portion of these funds were used to re-pay in full the debt outstanding with Silicon Valley Bank. We believe that our existing cash, cash equivalents and short-term investments at December 31, 2025 will be sufficient to fund our operations for the twelve months from the date of this report. If we encounter obstacles such as those that have been referred to above, we may not be able to return to operating cash flow breakeven on a quarterly basis, and additional capital may be required. Our direct billing revenues are concentrated with a small number of payers, including CMS. Adverse changes in the reimbursement policies of these payers regarding the MyoPro could have an adverse effect on our business. Revenues from providing the MyoPro directly to patients, a sales channel we refer to as direct billing, represented 74% and 78% of product revenues for the years ended December 31, 2025 and 2024, respectively. In 2024, we began providing the MyoPro to Medicare Part B patients. Revenues from patients with Medicare Part B represented 54% and 49% of total revenues for the years ended December 31, 2025 and 2024, respectively. Our historical focus on patients with commercial insurers who have previously reimbursed for the MyoPro also impacts our payer concentration. Beginning in September 2021, a large Medicare Advantage insurer that has historically reimbursed for the MyoPro began denying claims after having granted a pre-authorization and after we delivered the devices to patients, and these post-service denials currently continue. Revenues from patients insured by this payer represented 7% and 18% of total revenue during the years ended December 31, 2025 and 2024, respectively. With a small number of exceptions, appeals filed with the payer have been successful and these claims have ultimately been paid. However, this payer is now providing us with fewer pre-authorizations to serve new patients, requiring additional appeals efforts. This is common with other Medicare Advantage plans as well. If CMS were to change their coverage and reimbursement criteria for the MyoPro, or the aforementioned commercial payer and other Medicare Advantage payers further reduce the number of MyoPro’s that they will authorize for their insured patients, our revenues and cash flows would be negatively impacted, which would have an adverse effect on our business. We may experience significant fluctuations in our quarterly and annual results. Fluctuations in our quarterly and annual financial results have resulted and will continue to result from numerous factors, including: •timing, number and dollar value of reimbursements of our products by insurance payers; •changes in the mix of products we sell; 17•strategic actions by us, such as acquisitions of businesses, products, or technologies; •effects of domestic and foreign economic conditions and exchange rates on our industry and/or customers; •the divestiture or discontinuation of a product line or other revenue generating activity; •the relocation and integration of manufacturing operations and other strategic restructuring; •regulatory actions which may necessitate recalls of our products or warning letters that negatively affect the markets for our products; •costs incurred by us in connection with the termination of contractual and other relationships, including distributorships; •our ability to collect outstanding accounts receivable; •the expiration or exhaustion of deferred tax assets such as net operating loss carryforwards; •increased product and price competition, due to reimbursement of our products by Medicare, the regulatory landscape, market conditions or other factors; •technology changes to enhance individual data privacy that could negatively impact our ability to market our products to prospective candidates and could result in increased advertising costs;•market reception of our new or improved product offerings; and •the loss of any significant customer. These factors, some of which are not within our control, may cause the price of our common stock to fluctuate substantially. If our quarterly operating results fail to meet or exceed the expectations of securities analysts or investors, our stock price could drop suddenly and significantly. We believe quarterly comparisons of our financial results are not always meaningful and should not be relied upon as an indication of our future performance. Continued inflation may materially impact our financial operations or results of operations. While decreasing recently, inflation has and is expected to remain elevated for the near future. Inflationary factors, such as increases in the cost of our raw materials, manufacturing, interest rates and overhead costs may adversely affect our operating results. The price and availability of key components used to manufacture our products has been increasing and may continue to fluctuate significantly. In addition, the cost of labor internally or at our third-party manufacturers could increase significantly due to regulation or inflationary pressures. Additionally, the cost of logistics and transportation fluctuates in large part due to the price of oil, and availability can be limited due to political and economic issues. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some effect in the near future, especially if inflation rates continue to rise. Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations. While it has not had a material impact on our business to date, we sell our products in countries throughout the world and import materials into the United States. Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our products are difficult to predict and may have a material adverse effect on us. These developments may include export controls, tariffs or changes in reimbursement policies for Medicaid and Medicare. For example, on February 1, 2025, the U.S. imposed a 25% tariff on imports from Canada and Mexico, which was subsequently suspended for a period of one month. The U.S. has also imposed significant tariffs on imports from China and other countries, and these tariffs may continue to escalate, depending on the status of trade negotiations. Historically, tariffs have led to increased trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. While we estimate that tariffs assessed on our imports are expected to have less than a 100 basis point (1%) impact on gross margin in 2026, we cannot provide any assurance that the final tariffs actually imposed, changes in political, trade, regulatory, and economic conditions, 18including U.S. trade policies, will not have a material adverse effect on our financial condition or results of operations.
See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.